ZTALMY (ganaxolone suspension)

Self-Administration – oral

Diagnosis considered for coverage:
  • Indicated for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older
Coverage Criteria:

For diagnosis of CDD:

  • Dose does not exceed the maximum FDA recommended dose:
    • For patients weighing 28 kg or less: 63 mg/kg/day
    • For patients weighing more than 28 kg: 1,800 mg per day; AND
  • Patient is 2 years of age or older; AND
  • Patient has a documented diagnosis of cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD); AND
  • Documented mutation in the CDKL5 gene; AND
  • Prescribed by or in consultation with a neurologist; AND
  • Patient is experiencing motor seizures (e.g., bilateral tonic, generalized tonic-clonic, bilateral clonic, atonic, focal, or bilateral tonic-clonic); AND
  • Trial and failure, contraindication, or intolerance to two formulary anticonvulsants (e.g., valproic acid, levetiracetam, lamotrigine)
Reauthorization Criteria:

For diagnosis of CDD:

  • Dose does not exceed the maximum FDA recommended dose:
    • For patients weighing 28 kg or less: 63 mg/kg/day
    • For patients weighing more than 28 kg: 1,800 mg per day; AND
  • Documentation of positive clinical response to therapy as evidenced by a reduction in the frequency of seizures from baseline
Coverage Duration: 
  • Initial: 6 months
  • Reauthorization: 12 months
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • Ztalmy contains ganaxolone, a Schedule V controlled substance (CV)
Policy Updates:
  • 12/1/2022 – New policy approved by P&T
References:
  • Ztalmy Prescribing Information. Marinus Pharmaceuticals, Inc. Radnor, PA. June 2022.

Last review date: December 1, 2022

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